FDA product code QJD

Absorbable Metallic Bone Fixation Fastener

Orthopedic·Class 2·21 CFR 888.3041·Implantable·Life-sustaining
US regulatory classifications
US Product Code (FDA)
QJD
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3041
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
Yes
Third party review
Not Eligible
Definition

An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after steosynthesis is achieved.

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About this record

Absorbable Metallic Bone Fixation Fastener is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.